The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

• Status: Terminated
• Trial end date: 2014-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Budesonide; Peripheral Nervous System Agents

Criteria

Inclusion Criteria:

• Male or non-pregnant, non-breast-feeding females ≥18 years old.

• Participant was previously diagnosed with active mild to moderate UP/UPS and was currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study.

• Willingness to undergo sigmoidoscopy.

Exclusion Criteria:

• Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease).

• History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology.

• Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle.

• Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle.

• Participant took diuretics with cardiac glycosides.

• Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.